Scientist, Product Development

Position Summary

Plan, perform and analyze the results from scientific experiments leading to the design and development of genomic tests for in vitro diagnostic use based on the DxTerity Diagnostics technologies. Prepare protocols, reports, Work Instructions and other written materials that meet Quality System Requirements. Develop technical solutions to product design and performance issues while meeting ISO and FDA regulatory and design control requirements

Essential Duties

  • Work under the direct supervision of R&D management to achieve technical objectives within the scope of the overall projects.
  • Identify, test and implement solutions to defined technical and project issues based on scientific knowledge, evaluation of the scientific literature, and laboratory research.
  • Design, Develop and validate new genomic assays based on DxTerity’s proprietary technologies.
  • Perform laboratory studies to establish the design of multiplex assays according in order to meet project schedules.
  • Design protocols, perform experimental studies to evaluate and document the performance of prototype products relative to product performance and customer requirements.
  • Analyze data, evaluate results, form conclusions, and provide and/or implement product, process, or documentation improvements.
  • Document experimental protocols, results of studies and product design/development history in the form of laboratory notebook entries, written reports and/or company presentations. Documentation must meet ISO standards, FDA QSR requirements and/or protection of company intellectual property.
  • Prepare deliverables per DxTerity’s design control policy
  • Work closely with cross-functional team members in a collaborative environment.
  • Develop project and work plans.
  • Adjust work schedule to meet time-sensitive project milestones.


A PhD in Biochemistry, Molecular Biology or a related field and 1-3 years relevant experience, preferably in the clinical diagnostic products industry. Alternatively, a M.S. or B.S Degree in one of these fields and 3-5+ years of relevant industrial experience will be considered.


  • Previous experience working in a commercial IVD setting preferred.
  • Demonstrated ability to solve technical problems in an assay development and test validation environment.
  • Prior experience working in a QSR-compliant environment preferred.
  • Prior experience in all aspects of developing and commercializing new clinical molecular diagnostic products a plus.
  • Experience in developing and using new laboratory automation, and molecular biology methods desirable.

Key knowledge includes:

  • Broad knowledge of molecular biology and genomic analysis methods.
  • In depth knowledge of RNA analysis methods.
  • Advanced technical writing skills to produce reports and documents.

Key skills/abilities include:

  • Must have excellent technical and communication skills with experience in successful execution of scientific experiments and completion of projects.
  • Excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple and changing projects and priorities.
  • Excellent verbal and written communication skills and the ability to interpret and summarize scientific results in a clear, concise, accurate manner.
  • Demonstrated ability to identify, evaluate, and solve problems

Physical Demands Work entails regularly performing tasks in a laboratory environment and while working at a computer and/or desk. Work entails occasional lifting and/or moving up to 25 pounds. The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may occasionally be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and moderate levels of noise and vibration.


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